GlaxoSmithKline's Promacta gets FDA approval

LONDON--Research-based pharmaceutical and healthcare company GlaxoSmithKline PLC (GSK.LN) said Monday the U.S. Food and Drug Administration has approved Promacta for the treatment of thrombocytopenia [low blood platelet counts] in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy.

MAIN FACTS:

-There are limitations to the use of promacta in patients suffering from chronic hepatitis C-associated thrombocytopenia; these include:

* Promacta should not be used in an attempt to normalize platelet counts;

* Promacta should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon therapy or limits the ability to maintain optimal interferon-based therapy; and

* Safety and efficacy have not been established in combination with direct-acting antiviral agents approved for treatment of chronic hepatitis C genotype 1 infection.

-Shares at 1405 GMT up 8 pence, or 0.61%, at 1326 pence valuing the company at 64.77 billion pounds.

Intraday Data provided by SIX Financial Information and subject to terms of use.
Historical and current end-of-day data provided by SIX Financial Information.
All quotes are in local exchange time. Real-time last sale data for U.S. stock quotes reflect trades reported through Nasdaq only.
Intraday data delayed at least 15 minutes or per exchange requirements.